FDA.reportPublic FDA data

SHISEIDO BENEFIANCE WRINKLERESIST24 DAY

Product NDC
58411-628
11-digit product format
584110628
Labeler code
58411
Product ID
58411-628_47baa86d-0053-fbb4-e063-6394a90ad8d0
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE, OCTINOXATE, and OCTOCRYLENE
Dosage form
EMULSION
Route
TOPICAL
Labeler
SHISEIDO AMERICAS CORPORATION
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
AVOBENZONE; OCTINOXATE; OCTOCRYLENE
Active strength
1.94; 5.83; 1.55 g/75mL; g/75mL; g/75mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
SHISEIDO BENEFIANCE WRINKLERESIST24 DAY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE1.94 g/75mL
OCTINOXATE5.83 g/75mL
OCTOCRYLENE1.55 g/75mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
4Y5P7MUD51Internal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d308d578-c881-4c10-8c79-9e3cd58b694cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58411-628-10SHISEIDO BENEFIANCE WRINKLERESIST24 DAY1 in 1 CARTONEMULSION13
58411-628-10SHISEIDO BENEFIANCE WRINKLERESIST24 DAY75 mL in 1 BOTTLEEMULSION753

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58411-628SHISEIDO BENEFIANCE WRINKLERESIST24 DAY (AVOBENZONE, OCTINOXATE, AND OCTOCRYLENE) EMULSION [SHISEIDO AMERICAS CORPORATION]2Current NDC, Legacy NDC, 2 package rows20241225_d308d578-c881-4c10-8c79-9e3cd58b694c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 70 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RODAN AND FIELDS REVERSE 4 BROAD SPECTRUM SPF 50 PLUS SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fields7fe05ef6-dd5f-4f25-bbf7-24f9396427072026-01-23WarningsExact identifier
application number: M020
Ceile SPF 30 prime PROTECT RADIATE Broad Spectrum SPF 30 Sunscreen NacreCEILE SPF 30 PRIME PROTECT RADIATE NACRELE COSMETICS INC4915de09-3a2c-cb75-e063-6394a90a6a572026-01-23WarningsExact identifier
application number: M020
SPF 50 Sunscreen StickZINC OXIDEAustralian Gold248d761c-2120-4019-9463-9952bc367e732026-01-23WarningsExact identifier
application number: M020
SOLBAR THIRTYSUNSCREENPerson and Covey48ed3be8-d146-ec2c-e063-6394a90a6c4d2026-01-22WarningsExact identifier
application number: M020
MISSHA ALL AROUND ESSENCE SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f557b5-a844-8c94-e063-6394a90af2202026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW DEWY HDRATING SUNSCREENHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEAble C&C Co., Ltd.48f5e9ab-38e0-f12c-e063-6294a90aab8b2026-01-22WarningsExact identifier
application number: M020
MISSHA GLOW WEIGHTLESS PRIMING SUNSCREENZINC OXIDE, HOMOSALATE, OCTISALATE, TITANIUM DIOXIDEAble C&C Co., Ltd.48f6361d-d738-62df-e063-6294a90aaac52026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 35 AVOSUNSCREENPerson and Covey4a5692d5-0835-d18f-e063-6394a90a29292026-01-22WarningsExact identifier
application number: M020
Sunscreen Lip Balm SPF15OCTINOXATE, AVOBENZONE, OCTISALATEDongguan Taimeng Accessories Co., Ltd.48f70710-7960-5fa5-e063-6394a90a4ce62026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 ZINCSUNSCREENPerson and Covey48fc01dd-0be4-5c63-e063-6294a90a23622026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 40 SHIELDSUNSCREENPerson and Covey48fcd463-8ce4-1e78-e063-6394a90a98e72026-01-22WarningsExact identifier
application number: M020
SOLBAR SUNSCREEN 50 FIFTYSUNSCREENPerson and Covey48fef521-1b24-d0d5-e063-6394a90ac7b12026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 110HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.7456f4bb-d0ec-439d-b807-d00b4c01c1112026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 121HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.2dd51960-515f-4502-b261-5e5d5f57e0912026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 140HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5b835716-af13-4e23-bdae-d391864acb6f2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 132HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa258570-ee21-423d-bad6-010d14792a862026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 212HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.fa84c1b5-a9b6-408e-b9fd-0dadebaf374e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 221HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.6b7a016c-c3b1-4f90-80c9-fe47c52916492026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 151HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.5d029d93-7f3d-4624-bcd7-40df9230414e2026-01-22WarningsExact identifier
application number: M020
JAFRA ALWAYS LONG WEAR FOUNDATION BROAD SPECTRUM SPF 15 SUNSCREEN 232HOMOSALATE,OCTISALATE,ZINC OXIDEDistribuidora Comercial Jafra, S.A. de C.V.8f724d68-3c6e-4b95-894e-78b2da220a302026-01-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58411-628-10584110628101 BOTTLE in 1 CARTON (58411-628-10) / 75 mL in 1 BOTTLE1 bottle2021-01-010000-00-00NoNoCurrent